System and Method For Collecting And Treating Plasma Protein Fractions

Abstract

Method and apparatus for separating plasma from blood in a separation vessel, separating the separated plasma into desired plasma proteins in a plasma separator fluidly connected to the separation vessel to receive the separated plasma, and adding photosensitizer to the desired plasma proteins for viral inactivation treatment of such proteins.

1 . An method of collecting plasma fractions from whole blood comprising:
 rotating a separation vessel;   separating plasma from other blood components of the whole blood in the rotating separation vessel;   providing separated plasma from the rotating separation vessel to a plasma separator comprising a membrane wherein the membrane can separate at least some plasma proteins from the separated plasma;   separating the plasma into at least one fraction including desired plasma proteins using the plasma separator;   mixing the at least one fraction with photosensitizer;   collecting the at least one fraction with photosensitizer after the mixing step.   
     
     
         2 . The method of  claim 1  further comprising:
 returning any plasma and plasma proteins not collected in the collecting step back to the donor. 
 
     
     
         3 . The method of  claim 1  further comprising:
 separating red blood cells from other blood components in the rotating separation vessel; 
 collecting the separated red blood cells. 
 
     
     
         4 . The method of  claim 1  further comprising:
 radiating with photo-radiation the at least one fraction and photosensitizer after the collecting step. 
 
     
     
         5 . The method of  claim 1  wherein the mixing step comprises mixing with 7,8-dimethyl-10-ribityl isoalloxazine as the photosensitizer. 
     
     
         6 . The method of  claim 1  further comprising:
 providing the plasma separator comprising a hollow fiber membrane selected so that the separating the plasma step comprises:
 passing plasma and any plasma proteins not to be collected through the membrane. 
 
 
     
     
         7 . The method of  claim 6  wherein the passing step comprises passing plasma and any low molecular weight plasma proteins through the membrane. 
     
     
         8 . The method of  claim 1  further comprising radiating with photoradiation the at least one fraction and photosensitizer prior to the collecting step. 
     
     
         9 . The method of  claim 2  wherein the returning step comprises pumping any plasma and plasma proteins not collected back to the donor. 
     
     
         10 . The method of  claim 2  further comprising:
 separating red blood cells from other blood components in the rotating separation vessel; 
 collecting the separated red blood cells. 
 
     
     
         11 . The method of  claim 1  wherein the mixing step further comprises passing the at least one fraction through a cartridge containing photosensitizer in dry form to mix the at least one fraction with the photosensitizer prior to the collection step. 
     
     
         12 . The method of  claim 1  wherein the collecting step comprises collecting in a container. 
     
     
         13 . The method of  claim 12  wherein the mixing step comprises mixing in the container. 
     
     
         14 . The method of  claim 1  further comprising fractionating the at least one collected fraction in a plasma fractionation process to further concentrate the desired proteins in the at least one fraction. 
     
     
         15 . The method of  claim 14  wherein the step of fractionating the at least one collected fraction comprises precipitating out the desired proteins using cold alcohol fractionation. 
     
     
         16 . The method of  claim 1  further comprising filtering the at least one fraction to remove prion proteins. 
     
     
         17 . The method of  claim 1  further comprising:
 separating the plasma into a second fraction; 
 collecting the second fraction. 
 
     
     
         18 . The method of  claim 1  wherein the mixing occurs prior to the separating step. 
     
     
         19 . An apheresis plasma separation system comprising:
 a rotor;   a separation vessel mounted on the rotor for rotating therewith wherein blood is separated into plasma and other components in the separation vessel during rotation of the rotor;   a plasma separator fluidly connected to the separation vessel to receive the separated plasma from the rotating separation vessel;   the plasma separator comprising a membrane wherein the membrane can separate at least some plasma proteins from the separated plasma;   a collection container fluidly connected to the plasma separator for collecting the separated plasma proteins from the plasma separator.   
     
     
         20 . The system of  claim 19  wherein the other components include at least a red blood cell component and further comprising:
 at least one red blood cell collection container wherein any separated red blood components are collected in the red blood cell collection container. 
 
     
     
         21 . The system of  claim 19  further comprising:
 a plasma return assembly for returning uncollected plasma from the membrane plasma separator to the donor, said plasma return assembly comprising a tube interconnected to a second outlet on said membrane plasma separator. 
 
     
     
         22 . The system of  claim 22  further comprising a replacement fluid assembly fluidly connected to said plasma return assembly. 
     
     
         23 . The system of  claim 22  wherein the membrane separator comprises a hollow fiber membrane comprising an intercapillary space and an extracapillary space and wherein said inlet and said first outlet are in fluid communication with said intercapillary space and said second outlet is in fluid communication with said extracapillary space. 
     
     
         24 . The system of  claim 21  wherein the membrane has a pore size such that uncollected plasma and low molecular weight proteins pass through the membrane and from the plasma separator to the return assembly. 
     
     
         25 . The system of  claim 19  wherein a photosensitizer is in the collection container. 
     
     
         26 . The system of  claim 19  further comprising a cartridge between the plasma separator and the collection container and wherein the photosensitizer is in the cartridge. 
     
     
         27 . The system of  claim 26  wherein the photosensitizer is in dry form in the cartridge. 
     
     
         28 . The system of  claim 19  further comprising a pump for pumping separated plasma from the separation vessel to the plasma separator. 
     
     
         29 . The system of  claim 19  wherein the membrane separator comprises a hollow fiber membrane. 
     
     
         30 . The system of  claim 19  further comprising an illuminator for providing photoradiation to the separated plasma proteins and photosensitizer. 
     
     
         31 . The system of  claim 30  wherein the illuminator provides photoradiation to the separated plasma proteins and photosensitizer in the collection bag. 
     
     
         32 . The system of  claim 30  wherein the illuminator provides photoradiation to the separated plasma proteins and photosensitizer prior to collection in the collection container. 
     
     
         33 . The system of  claim 19  further comprising a prion filter between the plasma separator and the collection container to remove prions from the separated plasma proteins. 
     
     
         34 . The system of  claim 26  further comprising a prion filter between the plasma separator and the cartridge. 
     
     
         35 . The system of  claim 26  further comprising a prion filter between the cartridge and the collection container. 
     
     
         36 . The system of  claim 19  further comprising a second collection container for the other components of the separated plasma. 
     
     
         37 . The system of  claim 19  further comprising a cartridge containing the photosensitizer between the separation vessel and the plasma separator. 
     
     
         38 . The system of  claim 19  further comprising a prion filter between the separation vessel and the plasma separator. 
     
     
         39 . An integrated pre-connected disposable set for an apheresis system comprising:
 a removal/return assembly for removing and returning blood and blood components to a donor;   a separation vessel fluidly connected to the removal/return assembly and adapted for mounting on a centrifuge for rotation wherein whole blood is separated in the separation vessel during rotation of the centrifuge into at least plasma and other components;   a plasma collect assembly fluidly connected to the separation vessel to receive separated plasma comprising
 a membrane plasma separator for separating the separated plasma into at least a plasma protein fraction, said membrane plasma separator having an inlet and a first outlet; 
 photosensitizer in the plasma collect assembly; and 
 a collection container fluidly connected to the plasma separator to receive the plasma protein fraction and the photosensitizer. 
   
     
     
         40 . The disposable set of  claim 39  further comprising:
 a plasma return assembly for returning uncollected plasma from the membrane plasma separator to the donor, said plasma return assembly comprising a tube interconnected to a second outlet on said membrane plasma separator. 
 
     
     
         41 . The disposable set of  claim 40  further comprising a replacement fluid assembly fluidly connected to said plasma return assembly. 
     
     
         42 . The disposable set of  claim 39  wherein the membrane separator comprises a hollow fiber membrane comprising an intercapillary space and an extracapillary space and wherein said inlet and said first outlet are in fluid communication with said intercapillary space and said second outlet is in fluid communication with said extracapillary space. 
     
     
         43 . The disposable set of  claim 39  wherein the photosensitizer is located in the collection container. 
     
     
         44 . The disposable set of  claim 43  wherein the photosensitizer is in liquid form. 
     
     
         45 . The disposable set of  claim 39  further comprising:
 a cartridge between the membrane plasma separator and the collection container wherein the cartridge contains the photosensitizer. 
 
     
     
         46 . The disposable set of  claim 45  wherein the photosensitizer in the cartridge is in dry form. 
     
     
         47 . The disposable set of  claim 39  further comprising:
 a filter in the plasma collect assembly to filter prions from the separated plasma protein fraction. 
 
     
     
         48 . The disposable set of  claim 47  wherein the filter is between the membrane plasma separator and the collection container. 
     
     
         49 . The disposable set of  claim 45  further comprising:
 a filter in the plasma collect assembly to filter prions from the separated plasma protein fraction wherein the filter is between the cartridge and the collection container. 
 
     
     
         50 . The disposable set of  claim 43  wherein the photosensitizer is in dry form. 
     
     
         51 . The disposable set of  claim 45  further comprising:
 a filter in the plasma collect assembly to filter prions from the separated plasma protein fraction wherein the filter is between membrane plasma separator and the cartridge. 
 
     
     
         52 . The disposable set of  claim 39  further comprising a second collection container to receive the other separated components of the separated plasma. 
     
     
         53 . The disposable set of  claim 39  further comprising a cartridge between the membrane plasma separator and the separation vessel wherein the cartridge contains the photosensitizer. 
     
     
         54 . The disposable set of  claim 39  further comprising a prion filter between the plasma separator and the separation vessel.